A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 115
- 主要终点
- The Change in Serum Phosphorus for MCI-196 and Sevelamer
研究概览
简要总结
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
详细描述
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable haemodialysis or peritoneal dialysis treatment.
- •Stable phosphate control
- •Stabilised phosphorus diet.
- •female subjects of child-bearing potential must have a negative serum pregnancy test.
- •Male subjects must agree to use appropriate contraception.
- •Completed one of the MCI-196 PIII studies
排除标准
- •Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- •Body Mass Index (BMI) <= 16.0 kg/m2 or =>40.0 kg/m
- •Current or a history of significant gastrointestinal motility problems
- •Positive test for HIV 1 and 2 antibodies.
- •History of substance or alcohol abuse within the last year.
- •Seizure disorders.
- •History of drug or other allergy.
- •Temporary catheter with active signs of inflammation or infection.
- •The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
研究组 & 干预措施
2
干预措施: Another Phosphate binder (Sevelamer) (Drug)
1
干预措施: MCI-196 (Drug)
结局指标
主要结局
The Change in Serum Phosphorus for MCI-196 and Sevelamer
时间窗: 52 weeks (Baseline-52 weeks)
Change from Baseline to Week 52 (LOCF)
次要结局
- The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer(52 weeks (Baseline-52 weeks))